Xenios AG

Certificate G10 005119 0015

Rev. Rev. 00Issued

Valid until: Aug 26, 2029

Certificate G10 005119 0015 is a valid Quality management system issued to Xenios AG and registered in EUDAMED. Valid until August 26, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 005119 0015
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 005119 0015Rev. 00

Validity

Issued: Aug 27, 2024
Valid from: Aug 27, 2024
Valid until: Aug 26, 2029

Manufacturer

Manufacturer: Xenios AG
Manufacturer SRN: DE-MF-000006233
Manufacturer country: Germany

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

Z120502 - EXTRA-CORPOREAL CIRCULATION INSTRUMENTS
Class IIb

Documents

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